Regulatory Affairs Specialist – Ireland

About the role

The Specialist, Regulatory Affairs supports regulatory activities to maintain existing registrations and obtain new marketing authorisations across Europe. Working on assigned products at both local and European levels, the role acts as the primary regulatory contact with Health Authorities.

Key responsibilities

• Ensure compliance of all regulatory activities with local Health Authority requirements and company policies.
• Prepare, submit, obtain approval for and maintain Marketing Authorisations.
• Manage post‑approval activities such as variations, renewals, PSURs, RMPs, labeling changes and administrative updates.
• Coordinate regulatory documentation, submissions and tracking within regulatory systems.
• Collaborate with Quality, Supply, Medical and other cross‑functional teams to align regulatory strategies.
• Support supply‑related regulatory actions, including communication with Health Authorities and GMP‑related activities.
• Interact with National Health Authorities on regulatory matters and manage unregistered product supply.
• Monitor regulatory intelligence, competitive insights and share relevant information.
• Implement labeling updates (SmPC, PIL, packaging) and maintain compliant product artwork.
• Contribute to regulatory strategy development for marketed and pipeline products.

Required profile

• University degree in Life Sciences (Pharmacy or Pharmacology preferred).
• Minimum 2 years of experience in the pharmaceutical industry.
• At least 1 year of experience supporting European regulatory procedures (MRP, DCP, CP, WS) across multiple countries.
• Fluent written and spoken English; additional European language highly desirable.
• Ability to work with limited supervision and maintain scientific/regulatory knowledge in assigned therapeutic areas.

Required skills

• Proficiency with regulatory systems and tools such as Veeva, Ennov, Power BI and Microsoft Office applications.